FDA Approves Gadavist

U.S. FDA Approves Bayer's Gadavist (gadobutrol) Injection for MRI of the Central Nervous System

WAYNE, N.J., March 14, 2011 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration has approved Gadavist (gadobutrol) Injection, a macrocyclic gadolinium-based contrast agent (GBCA), for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system (CNS).

Gadavist is formulated at a higher concentration (1 mmol/mL) compared to certain other GBCAs. Compared to 0.5 molar gadolinium-based contrast agents, the higher concentration of Gadavist results in half the volume of administration and a more compact contrast bolus. It is important to closely examine the dosing table in the full prescribing information to determine the volume of Gadavist to be administered.

"The approval of Gadavist enriches our strong portfolio of MRI contrast media and provides a new option for U.S. healthcare providers in contrast-enhanced imaging of the CNS," said John Rotondo, Vice President, Commercial Operations, Bayer HealthCare Pharmaceuticals. "Our MR contrast agents are some of the most widely used today, and Bayer is proud to be a world leader in diagnostic imaging."

IMPORTANT SAFETY INFORMATION

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

  • The risk for NSF appears highest among patients with:
    • Chronic, severe kidney disease (GFR < 30 mL/min/1.73m(squared)), or
    • Acute kidney injury.
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended Gadavist dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions].



  • The possibility of serious or life-threatening hypersensitivity, anaphylactic or anaphylactoid reactions associated with cardiovascular, respiratory, or cutaneous manifestations, including death, should always be considered.
  • The most frequent adverse reactions associated with Gadavist in clinical studies were headache, nausea, injection site reaction, dysgeusia and feeling hot.

Please see full prescribing information at http://BayerImaging.com.

About the U.S. Phase III Trials

Patients referred for MRI of the central nervous system with contrast were enrolled in two clinical trials (Study A and Study B) that evaluated the visualization characteristics of lesions. In both studies, patients underwent a baseline, pre-contrast MRI prior to administration of Gadavist at a dose of 0.1 mmol/kg, followed by a post-contrast MRI. In Study A, patients also underwent an MRI before and after the administration of gadoteridol. The studies were designed to demonstrate superiority of Gadavist MRI to non-contrast MRI for lesion visualization. For both studies, pre-contrast and pre-plus-post contrast images (paired images) were independently evaluated by three readers for contrast enhancement and border delineation using a scale of 0 to 4, and for internal morphology using a scale of 0 to 3. Lesion counting was also performed to demonstrate non-inferiority of paired Gadavist image sets to pre-contrast MRI. Readers were blinded to clinical information.

For the visualization endpoints contrast enhancement, border delineation, and internal morphology, the percentage of patients scoring higher for paired images compared to pre-contrast images ranged from 93% to 99% for Study A, and 95% to 97% for Study B. For both studies, the mean number of lesions detected on paired images exceeded that of the pre-contrast images; 37% for Study A and 24% for Study B. There were 29% and 11% of subjects in which the pre-contrast images detected more lesions for Study A and Study B, respectively.

Gadavist provided a statistically significant improvement for each of the three lesion visualization parameters when averaged across three independent readers for each study. For both studies, the improvement of visualization endpoints in paired Gadavist images compared to pre-contrast images resulted in improved assessment of normal and abnormal CNS anatomy.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry. Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Gadavist is a trademark of Bayer. BAYER and the Bayer Cross are registered trademarks of Bayer.

SOURCE Bayer HealthCare Pharmaceuticals

CONTACT: Marcy Funk, Bayer HealthCare, marcy.funk@bayer.com, +1-973-305-5385

Web Site: http://www.bayer.com

Posted: March 2011

Gadavist (gadobutrol) FDA Approval History

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